AccessGUDID - DEVICE: LYKOS DTS (00858604006054)

GUDID

Device Identifier (DI) Information

Brand Name: LYKOS DTS
Version or Model: LYKOS DTS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAMILTON THORNE, INC.

Primary DI Number: 00858604006054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152161337 *Terms of Use

Device Description: This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61181	Assisted reproduction laser system	A portable, mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy. It is intended to be used in conjunction with a compatible inverted-stage light microscope and typically includes a combined laser/microscope objective, a control unit, a camera, and additional supportive devices (e.g., software, foot-switch).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRX	System, Assisted Reproduction Laser

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202241	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 116d6782-63ce-4b23-aac0-5d470a39945c
Public Version Date: June 15, 2023
Public Version Number: 1
DI Record Publish Date: June 07, 2023